hilar cholangiocarcinoma
Conditions
Brief summary
The primary endpoint is overall survival, i.e. time from randomization to death from any cause or to the last known date on which the patient was alive. The comparison between arms will be based on the hazard ratio as estimated from a Cox regression model.
Detailed description
Overall survival (complementary perspectives), Days alive and out of hospital up to two years, Quality of Life (QoL) at various points in time after randomization (V2 (14 days), V3 (ca. 3 months), as a function of time after 6 months, adjusting for the baseline value), Quality-adjusted life years (QALYs), Stent patency based on clinician’s assessment (e.g. cholangitis, cholestasis, ultrasound), Laboratory parameters, Pruritus as a function of time up to two years will be considered
Interventions
DRUGFoscan 1 mg/ml solution for injection
DRUGPORFIMER SODIUM
Sponsors
University Of Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is overall survival, i.e. time from randomization to death from any cause or to the last known date on which the patient was alive. The comparison between arms will be based on the hazard ratio as estimated from a Cox regression model. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (complementary perspectives), Days alive and out of hospital up to two years, Quality of Life (QoL) at various points in time after randomization (V2 (14 days), V3 (ca. 3 months), as a function of time after 6 months, adjusting for the baseline value), Quality-adjusted life years (QALYs), Stent patency based on clinician’s assessment (e.g. cholangitis, cholestasis, ultrasound), Laboratory parameters, Pruritus as a function of time up to two years will be considered | — |
Countries
Germany
Outcome results
None listed